Method and device for full thickness resectioning of an organ

ABSTRACT

A full-thickness resection system comprises a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism comprises an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism.

FIELD OF THE INVENTION

The present invention relates to full thickness resection devices forperforming localized resections of lesions in tubular organs,particularly the colon.

BACKGROUND INFORMATION

A resection procedure involves excising a portion of an organ,approximating the surrounding tissue together to close up the holecreated by the excision, and removing the excess tissue. Variousconventional devices and procedures are available for resectioninglesions in tubular organs.

For example, several known resection devices and procedures requires atleast one incision in an area near the portion of the organ to beexcised for access to the lesion or treatment site (because, forexample, the resectioning device may lack steering and/or viewingcapabilities). Thus, the incision is required to allow the physician toaccess the organ section to be excised and guide the device to thatsection. Alternatively, when the organ section to be excised is beyondthe reach of the surgical device, or the surgical device is not flexibleenough to wind through the organ to the site to be excised, an incisionwill be required to position the device for the procedure. Of course,these incisions are painful and may involve a partial or entire loss ofmobility while recuperating from the incision, in addition to recoveringfrom the tubular resectioning procedure itself. In addition, the timerequired to recover from such a procedure is often longer than forprocedures which do not require incisions.

One type of conventional resection procedure utilizes a circularstapling instrument in which a tubular section of a tubular organ isexcised, resulting in the tubular organ being separated into a firstsegment and a second segment. The end sections of the first and secondsegments are then individually tied in a purse-string fashion,approximated, stapled, and the "purse-stringed" end sections are thencut off. In this full circle resectioning procedure, at least oneseparate invasive incision must be made near the section to be excisedin order to cut and individually tie the separate end sections of theorgan. Also, a separate incision is necessary to place one part of theresectioning device in the first segment and a corresponding second partof the device in the second segment so that the device can then bringthe first and second segments together to re-attach the organ sectionsback together. A first of these separate parts may generally include astaple firing mechanism while the second part includes an anvil forforming the staples. Thus, this type of resectioning procedure involvesthe drawbacks mentioned above in regard to procedures requiring invasiveincisions. In addition, the separation of the organ into two segmentscreates the risk of spillage of non-sterile bowel contents into thesterile body cavity, which can cause severe infection and possiblydeath.

An alternative resectioning device includes a stapling and cuttingassembly on a shaft which can be bent or formed into a desired shape andthen inserted into a patient's body cavity. Once the shaft has been bentinto the desired shape, the rigidity of the shaft ensures that thatshape is maintained throughout the operation. This arrangement limitsthe effective operating range of the device as the bending of the shaftinto the desired shape before insertion and the rigidity of the shaftonce bent require the physician to ascertain the location of the organsection to be removed before insertion, and deform the shaftaccordingly. Furthermore, the rigidity of the shaft makes it difficultto reach remote areas in the organ--particularly those areas which mustbe reached by a winding and/or circuitous route (e.g., sigmoid colon).Thus, an incision may be required near the organ section to be excisedin order to position the device at the organ section to be excised.

SUMMARY OF THE INVENTION

The present invention is directed to a full-thickness resection systemcomprising a flexible endoscope and a stapling mechanism, wherein theendoscope is slidably received through at least a portion of thestapling mechanism. The stapling mechanism includes an anvil and astapling head mounted to the anvil so that the anvil and the staplinghead are moveable with respect to one another between a tissue receivingposition and a stapling position and wherein a gap formed between thestapling head and the anvil is larger in the tissue receiving positionthan it is in the stapling position. A position adjusting mechanism isprovided for moving the anvil and the stapling head between the tissuereceiving and stapling positions and a staple firing mechanismsequentially fires a plurality of staples from the stapling head acrossthe gap against the anvil and through any tissue received in the gap anda knife cuts a portion of tissue received within the gap. A control unitwhich remains outside the body is coupled to the stapling mechanism forcontrolling operation of the position adjusting mechanism and the staplefiring mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device according to a first embodiment of the presentinvention;

FIG. 2 shows the device of FIG. 1 mounted on a conventional endoscope;

FIG. 3 shows the device of FIG. 1 with a grasper mechanism extendingtherefrom;

FIG. 3A shows the device of FIG. 1 where the anvil member is pivotallycoupled to the mounting shafts;

FIG. 4 shows a cutaway of the device of FIG. 1 showing a drive mechanismthereof;

FIG. 5 shows a cutaway of the device of FIG. 1 showing an actuatingmechanism;

FIG. 6 shows a detailed view of the wedge used in the actuatingmechanism of FIG. 5;

FIG. 7 shows a cut-away view of a working head assembly of the device ofFIG. 1;

FIG. 8 shows a rear cover plate of the working head assembly of FIG. 7;

FIG. 9a shows a mechanism for restricting motion of a drive shaft of thedevice of FIG. 1;

FIG. 9b shows a first coupling arrangement for a drive cable and a driveshaft in the device of FIG. 1;

FIG. 9c shows a second coupling arrangement for the drive cable and thedrive shaft in the device of FIG. 1;

FIG. 9d shows a perspective cut-away view of a sheath of the device ofFIG. 1;

FIG. 10a shows a perspective view of an alternative construction of thewedge of FIG. 6;

FIG. 10b shows a cut-away view of the wedge of FIG. 10a;

FIG. 10c shows a blade portion corresponding to the wedge of FIG. 10a;

FIG. 11 shows a device according to a second embodiment of the presentinvention;

FIG. 12 shows a device according to a third embodiment of the presentinvention;

FIG. 13 shows a device according to a fourth embodiment of the presentinvention;

FIG. 14a shows a device according to a fifth embodiment of the presentinvention;

FIG. 14b shows a detailed cut-away view of the device of FIG. 14a and aconventional endoscope;

FIG. 15 shows a control handle for use with the devices according to thepresent invention;

FIG. 16 shows a blade housing arrangement for use with a deviceaccording to the present invention;

FIG. 17 shows a first arrangement of a blade shield for use with adevice according to the present invention;

FIG. 18 shows a second arrangement of the blade shield for use with adevice according to the present invention;

FIG. 19a shows a third arrangement of the blade shield for use with adevice according to the present invention;

FIG. 19b shows a tissue blocker of the blade shield of FIG. 19a;

FIG. 19c shows a distal end of a proximal housing of the device of FIG.19a; and

FIG. 20 shows a device according to a sixth embodiment of the presentinvention.

FIG. 21 shows a device according to a seventh embodiment of the presentinvention.

FIG. 22 shows a first perspective view of the device of FIG. 21.

FIG. 23 shows a second perspective view of the device of FIG. 21.

FIG. 23a shows a third perspective view of the device of FIG. 21.

FIG. 24 shows a side cut-away view of the device of FIG. 21.

FIG. 25 shows a fourth perspective view of the device of FIG. 21.

FIG. 26 shows a cut-away view of an exemplary stapler member of thedevice of FIG. 1.

DETAILED DESCRIPTION

As shown in FIGS. 1 and 2, an apparatus according to a first embodimentof the present invention comprises a working head assembly 2 which maypreferably be connected to a distal end 4a of a sheath 4. The proximalend 4b of the sheath 4 may preferably be connected to a control handle6.

In operation, the entire apparatus is mounted onto an endoscope 8,having a proximal end 8a and a distal end 8b by passing the endoscope 8through the control handle 6, the sheath 4, and the working headassembly 2, as shown in FIG. 2. The endoscope 8 is then inserted into abody orifice to locate a lesion in the tubular organ under visualobservation (usually while insufflating the organ). Once the lesion hasbeen located, the working head assembly 2 and the sheath 4 are slidablyadvanced along the endoscope 8 into the tubular organ until the workinghead assembly 2 is in a desired position adjacent to the lesion. Thoseskilled in the art will understand that in an alternative embodiment,the working head assembly 2 may also be detachably coupled to a distalend of the endoscope 8, and the entire arrangement may then be insertedinto the body orifice under visual observation.

As shown in FIG. 1, the working head assembly 2 comprises an anvilmember 10 coupled to a distal end 12a of a proximal housing 12. Theanvil member 10 has a substantially crescent-shaped cross-section (i.e.,the outer edge 18 of the anvil member 10 substantially forms a portionof a first circle with a second smaller circular cut-out 13 formedwithin the first circle) with a proximal face 14 and a smaller distalface 16. The cut-out 13 of the anvil member 10 is included to allow theendoscope 8 to be slid through the entire working head assembly 2 sothat the endoscope 8 may be advanced into the body passage allowing theworking head assembly 2 to later be advanced into the body to thelesion. In addition, the cut-out 13 also provides forward vision via theendoscope 8. Thus, any shape of the cut-out 13 may be selected which islarge enough to accommodate the endoscope 8, with a larger cut-outproviding a larger field of vision. An outer surface 18 of the anvilmember 10 extends substantially parallel to a central axis of theworking head assembly 2 while the proximal and distal faces 14, 18 ofthe anvil member 10 extend in planes substantially perpendicular to thecentral axis. The outer surface 18 is joined to the distal face 16 by atapered portion 5.

As shown in FIG. 3, the proximal face 14 of the anvil member 10 includesa first cavity 37 and a rim 41 encircling the first cavity 37. Aplurality of staple-forming grooves 19 are arranged in two offset rowson the rim 41 of the anvil member 10 and a circular guiding slit 21extends radially within the rows of grooves 19. The rim 41 protrudesfrom the remainder of the proximal face 14 so that a shallow cavity isformed on the proximal face 14.

The anvil member 10 is coupled to the proximal housing 12 by means oftwo mounting shafts 20a and 20b, which may preferably be substantiallycylindrical. Each mounting shaft 20a, 20b is coupled to the proximalface 14 of the anvil member 10 on a respective one of two horns 22a, 22bformed by the crescent-shaped anvil member 10. Although the anvil member10 is shown fixedly coupled to the mounting shafts 20a, 20b, thoseskilled in the art will understand that the anvil member 10 may also bepivotally coupled to the mounting shafts 20a, 20b in order to provide agreater field of vision through the endoscope 8 as shown in FIG. 3a. Inthis pivoted-type arrangement, the anvil member 10 is angled in a firstconfiguration so that the horns 22a, 22b are closer to the distal end12a of the proximal housing than the rest of the anvil member 10. Then,as the anvil member 10 is drawn towards the distal end 12a of theproximal housing 12, the anvil member 10 would be pressed against thedistal end 12a beginning with the horns 22a, 22b, which would cause theanvil member 10 to pivot until the proximal face 14 of the anvil member10 is parallel to the distal end 12a.

As shown in FIG. 1, the mounting shafts 20a, 20b are slidably receivedin mounting holes 26a, 26b, which have a size and shape substantiallycorresponding to the size and shape of the mounting shafts 20a, 20b andwhich run axially through the proximal housing 12. The mounting shafts20a, 20b are preferably movable axially proximally and distally withinthe mounting holes 26a, 26b between a proximal most position in which atissue gripping gap of a first predetermined width is formed between therim 41 and the distal end 12a of the proximal housing 12, and a distalmost position in which a tissue receiving gap of a larger secondpredetermined width is formed between the rim 41 and the distal end 12aof the proximal housing 12.

The second predetermined width should preferably be more than twice thethickness of a wall of the organ being resectioned so that a section ofthe tubular organ may be pulled into a resectioning position between theanvil member 10 and the proximal housing 12.

As shown in FIG. 4, the proximal end of at least one of the mountingshafts 20a and 20b is coupled to a drive mechanism 102 provided withinthe proximal housing 12. In a preferred embodiment, the drive mechanism102 is composed of a yoke 103 and a drive shaft 105. The yoke 103 ispreferably slidably received within the proximal housing 12 forlongitudinal movement along the axis of the proximal housing 12 so that,when the anvil member 10 is in the proximal most position, the yoke 103is in a corresponding proximal most position and, when the anvil memberis in the distal most position, the yoke 103 is in a correspondingdistal most position.

The yoke 103 may preferably be substantially semicircular with asubstantially rectangular cross-section. Although the semicircle formedby the yoke 103 in FIG. 4 forms substantially a quarter arc of a circle,the yoke 103 may form a larger semicircle based upon the interioraccommodations of the proximal housing 12 and the position of themounting shafts 20a, 20b. The mounting shaft 20a may preferably becoupled to the yoke 103 at a first end 103a of the yoke 103, and themounting shaft 20b may be coupled at a second end 103b of the yoke 103.A shaft hole 107, having a diameter substantially corresponding to adiameter of a complementarily threaded distal end 105a of the driveshaft 105, extends through the yoke 103 at a point substantially midwaybetween the first end 103a and second end 103b. Thus, when the driveshaft 105 is rotated, the threaded distal end 105a engages the shafthole 107 to move the yoke 103 proximally or distally (in dependence uponthe direction of rotation of the drive shaft 105).

The distal end 105a of the drive shaft 105 should preferably be threadedover a first section 105t substantially corresponding in length to atleast the distance between the proximal and distal most yoke positions,while a remainder portion 105r may have no threads thereon. The driveshaft 105 may have an increased cross-section in the areas immediatelyadjacent to the threaded first section 105t (proximally and/or distallyof section 105t), thereby limiting the movement of the yoke 103 to thefirst section 105t. Those skilled in the art will understand that thedrive shaft 105 is preferably rotatably mounted within the proximalhousing 12 so that it may only rotated and may not move relative to theproximal housing 12. The drive shaft 105 preferably extends to aproximal end 105b which is coupled to a drive cable 100 which extends tothe control handle 6 through the sheath 4. The drive cable 100 maypreferably run axially along the peripheral interior of the sheath 4.Those skilled in the art will understand that the sheath 4 is preferablytorsionally stiff to resist the torque forces from the drive cablesrotating therein. However, the sheath 4 is longitudinally flexible to sothat it may be slidably advanced along the endoscope 8, while minimizinginterference with the operation of the endoscope 8 and trauma tosurrounding tissue. The sheath 4 is preferably constructed similar toknown endoscope insertion tubes, which are flexible yet allow thetransfer of forces to swivel the distal end of the endoscope 8 inmultiple directions nd the torqueable rotation of the endoscope.

FIGS. 7-10 show a cutaway view of the working head assembly 2 in FIG. 1,in which the respective movements of the drive shaft 105 and the yoke103 are restricted in the manner described above. As shown in FIG. 8, apear-shaped rear cover plate 460 may preferably be connected to theproximal end 12b of the proximal housing 12. A first shaft hole 462having a cross-sectional size substantially corresponding to thecross-sectional size of the drive shaft 105 is provided in a lowerportion of the rear cover plate 460 for receiving the drive shaft 105therethrough. Thus, the yoke 103 is restricted to only longitudinalmovement in this arrangement because, the distal side of the yoke 103 iscoupled to the mounting shafts 20a, 20b which are disposed in themounting holes 26a, 26b, and the proximal side of the yoke 103 iscoupled to the drive shaft 105 which is disposed in the first shaft hole462.

As shown in FIG. 9a, the movement of the drive shaft 105 may berestricted to only rotation movement about its axis by two washer-typedevices 470 fixedly attached to the drive shaft 105 on either side ofthe rear cover plate 460. A similar result may be achieved by providingthe drive shaft 105 with a larger cross- sectional size on either sideof the rear cover plate 460 in relation to the portion of the driveshaft 105 within the rear cover plate 460. Alternatively, thecross-section of a bulging portion 476 of the drive shaft 105 locatedsubstantially in the center of the rear cover plate 460 may be largerthan the portions of the drive shaft 105 immediately adjacent to thebulging portion 476. The first shaft hole 462 may then have a centerportion 474 with a larger cross-section than the rest of the first shafthole 462 to accommodate the bulging portion 476 of the drive shaft 105.

FIG. 9b shows a coupling arrangement between the drive cable 100 and thedrive shaft 105 in which a proximal end 105a of the shaft may have aD-shaped hole 105h extending therethrough. A distal end 102b of thedrive cable 100 has a D-shape corresponding to the shape of the hole105h so that the distal end 102b of the drive cable may be receivedwithin the hole 105h in the drive shaft 105. FIG. 9c shows analternative coupling arrangement for coupling the drive cable 100 to thedrive shaft 105 in which the hole 105h in the proximal end 105a of thedrive shaft 105a and the distal end 102b of the drive cable 100 havecorresponding squarish shapes. The single edge provided by the D-shapesin FIG. 9b and the four edges provided by the squarish shapes in FIG. 9callow the drive cable 100 to transfer a rotational force to the driveshaft 105 with minimal slippage.

In operation, the user advances the endoscope 8, with the working headassembly 2 received therearound, to a portion of tissue to beresectioned until the working head assembly 2 is in a desired positionadjacent to the tissue to be resectioned. The user may then apply aforce to the control handle 6 to rotate the drive cable 100 which inturn rotates the drive shaft 105 to advance the yoke 103 and the anvilmember 10 distally away from the distal end 12a of the proximal housing12. As shown in FIG. 3 when the anvil member 10 has reached the distalmost position, a known grasping device 108 is advanced through thesheath 4 and through the working head assembly 2 to enter the gapbetween the anvil member 10 and the distal end 12a via one of thegrasper holes 32 and 33. Although the device in FIG. 3 is shown using aduodenoscope as the endoscope 8, those skilled in the art willunderstand that other types of endoscopes may also be used, such as, forexample, gastroscope, colonoscope, etc.

As shown in FIG. 1, at least the distal end 12a of the proximal housing12 preferably has a cross-section corresponding in size and shape to theproximal face 14 of the anvil member 10, including a cut-out 29substantially corresponding in size and shape to the cutout 13 of anvilmember 10. The cut-out 29 is provided to receive the endoscope 8 thereinand allow the proximal housing 12 to be slidably advanced along theendoscope 8. Of course, those skilled in the art will understand thatthe shape of the outer surface of the working head assembly 2 may beselected in order to accommodate various desired resectioning shapes,and the shape of the anvil member 10 may preferably be selected to forma continuous surface when positioned adjacent to the proximal housing 12to facilitate advancing the working head assembly to into and removingit from, body passages. It is preferable that the working head assemblyhave a maximum diameter at any point between 15 mm and 40 mm.

A tissue receiving cavity 30 is formed substantially centrally in thedistal end 12a of the proximal housing 12 to facilitate the drawing ofsections of tubular organs into the gap between the anvil member 10 andthe distal end 12a. Those skilled in the art will understand that thedepth of the cavity 30 may vary depending on the amount of tissue to bepulled into the cavity 30 and the size of the proximal housing 12. Twograsper holes 32 and 33 extend axially, preferably slightly off-centerfrom the longitudinal axis of the proximal housing 12. In a preferredembodiment, the grasper holes 32 and 33 may each preferably receive agrasping device 108 advanced from the control handle 6, through thesheath 4, and through a respective one of the grasper holes 32 and 33.

In operation, either one or two grasping devices 108 may then be used topull a section of the tubular organ between the anvil member 10 and thedistal end 12a of the proximal housing 12 and into the cavity 30. Athird grasping device 108 may also be inserted through the workingchannel of the endoscope 8 to provide another means of positioning theorgan section between the anvil member 10 and the proximal housing 12.Of course, those skilled in the art will understand that any desiredinstrument may be advanced to the gap between the anvil member 10 andthe distal end 12a through any of the grasper holes 32, 33 and theworking channel of the endoscope 8.

A plurality of staple slits 34 are preferably disposed in two offsetsubstantially circular rows extending along the periphery of the distalend 12a of the proximal housing 12. The staple slits 34 extend from anarea adjacent to the mounting shaft 26a to an area adjacent to the othermounting shaft 26b. The plurality of staple slits 34 may preferably bearranged so that when the anvil member 10 is in the proximal mostposition, each of the staple slits 34 is aligned with a correspondingone of the staple-forming grooves 19.

When the device is configured for operation, a plurality of staples isreceived within the working head assembly 2 with each of the staplesbeing aligned with a respective one of the staple slits 34. The staplesare then sequentially fired from the respective staple slits 34 by anactuating mechanism 104 (shown in FIG. 5) disposed in the proximalhousing 12.

A substantially circular blade slit 36 extends substantially radiallywithin the staple slits 34 so that, when the anvil is in the proximalmost position, the blade slit 36 is aligned with the guiding slit 21 onthe anvil member. As shown more clearly in FIG. 12, extensions 84a and84b of the blade slit 36 extend into blade housings 74a and 74b,respectively, which project distally from the distal end 12a of proximalhousing 12. The blade housings 74a and 74b are preferably situated sothat when the anvil member 10 is in its proximal most position, theblade housings 74a and 74b contact portions 43a and 43b of the rim 41 ofthe anvil member 10. The extension of the blade housings 74a and 74bfrom the proximal housing 12 is preferably selected so that when theblade housing devices 74a and 74b engage the remainder portions 43a and43b of the rim 41 (thereby stopping a proximal movement of the anvilmember 10 and defining the proximal most position thereof), a gap isformed between the anvil member 10 and the distal end 12a of a lengthsufficient to allow the anvil member 10 to securely hold a portion ofthe organ against the proximal housing 12 without crushing and damagingthe portion of the organ.

When positioned at one end of the blade slit 36 (i.e., in one of theextensions 84a and 84b), a cutting blade 202 is preferably completelyenclosed within the respective one of the blade housing devices 74a and74b and the guiding slit 21, so that the cutting blade 202 does not cutany tissue until the physician intentionally operates the blade 202.When the physician operates the blade 202, the blade 202 is driven fromits initial position received within one of the extensions 84a and 84baround the blade slit 36 with its cutting edge facing a direction ofmovement, until the blade 202 is received into the other one of theextensions 84a and 84b. Thus, after a cutting operation has beenperformed, the blade 202 is once again prevented from inadvertentlyinjuring the patient.

FIG. 6 shows a wedge 402, a first portion 402a of which is non-rotatablycoupled to an actuating shaft 400 so that rotation of the shaft 400 thewedge 402 rotates, preferably about the longitudinal axis of the workinghead assembly 2. The wedge 402 includes a blade handle 408 which extendsfrom a first portion 408a coupled to the wedge 402 to a second portion408b which is coupled to the blade 202 so that, when the wedge 402 isrotated, the blade 202 is rotated through the blade slit 36. The wedge402 has a substantially bell-like cross-section when viewed axially,with a second portion 402b extending radially outward from the firstportion 402a and, consequently, from the longitudinal axis of the shaft400 which preferably coincides with the longitudinal axis of the workinghead assembly 2. A notch of varying depth is cut out of a radially outerportion of the second portion 402b to form a cam surface 412 thereon. Afirst ramp section 412a ramps up from a leading face 402d of the wedge402 to adjoin a second ramp section 412b that ramps down to adjoin arear face 402e of the wedge 402. The wedge 402 is preferably arranged inthe proximal housing 12 so that the cam surface 412 is substantiallyaligned with the staple slits 34.

A staple driver 472 extends substantially longitudinally, proximallyfrom each of the staple slits 34 having toward the plane in which thewedge 402 rotates and each staple driver 472 is slidably received withinthe working head assembly 2 for motion between a distal most, stapledriving position and a proximal most inoperative position. In theinoperative position, an upper end of each of the staple drivers 472 iscompletely received within the proximal housing 12, just proximal of arespective staple. The staple drivers 472 are preferably substantiallyrectangular in shape, although bottom edges 472a thereof may morepreferably be rounded.

The length of the staple drivers 472 is preferably selected so that, inthe inoperative position, the bottom surfaces 472a extend into the planeof rotation of the wedge between the proximal and distal most extents ofthe first ramp portion 412a. The bottom surfaces 472a are, in theinoperative position, more preferably substantially aligned with thedistal most projection of the of the cam surface 412 at the leading face402d. Thus in operation, the wedge 402 is rotated by the actuating shaft400 so that the first ramp section 412a of the cam surface 412successively drives each of the staple drivers 472 into contact with acorresponding staple so that each staple driver 472 and its staple aredriven distally through a respective one of the staple slits 34. Thisdrives the staples across the gap from the distal end 12a into the anvilmember 10, through any tissue held between the anvil member 10 and theproximal housing 12, and into the corresponding staple forming grooves19. Thus the section of the tissue gripped between the anvil member 10and the proximal housing 12 is stapled in a pattern substantially thesame as that formed by the staple slits 34 (i.e., substantiallycircular). At the same time, the blade 202 is rotated through the bladeslit 36 to cut the tissue which has just been stapled through therotation of the wedge 402.

After each of the plurality of staples has been fired, the wedge 402 maybe driven in a reverse direction to reload a new plurality of staples.The wedge 402 may rotate in a direction opposite the staple firingdirection without getting caught on any of the staple drivers 472because the staple drivers are pushed out of the way by the second rampsection 412b of the cam surface 412.

In operation, the user applies a force to the control handle 6 to rotatean actuating cable 450 about its longitudinal axis. This rotationalforce is transferred to the actuating shaft 400, which then rotates thewedge 402 around the longitudinal axis of the actuating cable 450. Thefirst ramp section 412a of the cam surface 412 of the wedge 402 thenindividually drives the staple drivers 472 distally as described aboveto staple the tissue received between the anvil member 10 and theproximal housing 12 with the cutting blade 202 lagging behind the firingof the stapling since the blade handle 408 is coupled to the rear face402e of the wedge.

FIG. 10a shows an alternative configuration of the wedge 402 of FIG. 6including a separate blade portion 420. The blade portion 420 ispreferably rotatably coupled to the distal end 400a of the actuatingshaft 400 so that a rotation of the actuating shaft 400 about itslongitudinal axis does not cause a corresponding rotation of the bladeportion 420. As in FIG. 6, the wedge 202 of this apparatus isnon-rotatably coupled to the distal end 400a of the shaft 400.

The blade handle 408 of this apparatus, which is coupled to a peripheraledge 420e of the blade portion 420, extends to the cutting portion ofthe blade 202. As described above, the cutting portion of the blade 202extends past the distal end 12a except when the blade 202 is receivedwithin one of the extensions 84a and 84b.

The wedge 402 substantially corresponds in shape and size to the wedge402 of FIG. 6, except that the blade handle 408 is not coupled thereto.In addition, a locking shaft 402h extends into a distal surface 402tlocated as shown in FIG. 10a so that when the blade portion 420 and thewedge portion 410 are aligned, the locking shaft 402h and a lockingdimple 414 (shown in FIG. 10c) on the bottom face 420b of the bladeportion 420 are substantially aligned. As shown in FIG. 10b, a spring416 is received within the locking shaft 402h with a proximal end of thespring coupled to the proximal end of the locking shaft 402h. A lockingball 418 coupled to the distal end 416b of the spring 416 is sized sothat when a proximally directed force is applied to the locking ball418, the locking ball 418 may be slidably received within the lockingshaft 402h. In addition, when no distally directed force is applied tothe locking ball 418, the spring 416 preferably extends so thatapproximately one half (or more) of the locking ball 418 extendsdistally out of the locking shaft 402h. Thus, when the wedge 402 isrotated toward the blade portion 420, the locking ball 418 is receivedin a cut-out 425 formed on the proximal surface 420b of the bladeportion 420. As shown in FIG. 10c, the cut-out 425 slopes downward toadjoin the locking dimple 424 so that when the locking ball 418 isreceived, the slope of the cutout 425 gradually pushes the locking ball418 into the locking shaft 420h. Then, when the wedge 402 moves intoalignment with the blade portion 420, the locking ball 418 extends outof the locking shaft 402h and enters the locking dimple 414 to couplethe wedge 402 to the blade portion 420 so that a rotation of the wedge402 causes a corresponding rotation of the blade portion 420.

A radial length B₁ between the peripheral edge 420e of the blade portion420 and the actuating shaft 400 may substantially correspond to a radiallength W₁ between the wall 402f of the wedge portion 410 and theactuating shaft. This places the blade handle 408 in substantially thesame position, relative to the cam surface 402c of the wedge portion410, as in the previous embodiments. Of course, those skilled in the artwill understand that it is important that the blade 408 should extendsubstantially distally to the blade slit 36 so that rotation of theblade portion 420 will cause a corresponding rotation of the blade 202through the blade slit 36.

In operation, the wedge 402 is initially situated distally of one of theblade housings, e.g., 74a while the blade portion 420 is situateddistally of the blade housing 74b with the blade 202 received in theblade housing 74b. When the lesion tissue has been drawn into positionbetween the distal end 12a and the anvil member 10, the physicianactuates the shaft 400 by applying a force at the control handle 6. Thiscauses the wedge portion 410 to rotate distally of the staple slits 34,to sequentially drive each of the staple drivers 472 distally throughthe corresponding staple slit 34. When the wedge 402 has rotated fullyinto alignment with the blade portion 420 and the locking ball 418 isreceived into the locking dimple 414, the operator then operates thecontrol handle 6 in the opposite direction to draw the blade 202 out ofthe blade housing 74b to cut all of the tissue extending radially inwardof the rows of staples. When the blade 202 is received in the otherblade housing 74a, the wall of the body passage is released and thelesion tissue remains within the gap between the distal end 12a and theanvil member 10 held by the grasping devices 108. The lesion tissue maythen be withdrawn from the body for analysis. This embodiment of thewedge 402 provides a safeguard in case the stapling process must beprematurely aborted due to, for example, a jam in one of the stapleslits 34. Using this embodiment, the cutting process is not begun untilall of the staples have been fired. Thus, it is possible to reduce therisk of cutting an opening in an organ which is not completely closed bythe staples.

As shown in FIG. 5, the actuating mechanism 104 includes the actuatingcable 450 which extends from a proximal end 450a coupled to the controlhandle 6 to a distal end 450b coupled to the proximal end 400a of theactuating shaft 400. Those skilled in the art will understand that thewedge 402 should preferably be situated towards the distal end 12a ofthe proximal housing 12 so that the yoke 103 does not interfere withrotation of the wedge 402 around the longitudinal axis of the actuatingshaft 400 (discussed below) even when the yoke 103 is in its distal mostposition.

As shown in FIGS. 7-9a, the rear cover plate 460 may preferably becoupled to the proximal end 12b of the proximal housing 12. The proximalend 12b of the proximal housing 12 is then connected to the sheath 4.The actuating shaft 400 may preferably extend through a second shafthole 464 formed in the rear cover plate 460 of the proximal housing 12and preferably abuts an interior portion of the cavity 30 provided onthe proximal housing 12. An endoscope hole 466 may preferably beprovided on a portion of the rear cover plate 460 radially separatedfrom the longitudinal axis of the working head assembly 2 to guide theendoscope 8 into the cut-out 29 of the proximal housing 12. Theendoscope 8 may preferably be received into the endoscope hole 466 froman endoscope lumen 40 provided within the sheath 4 which is preferablydisposed along a periphery of the sheath.

FIG. 9d shows a perspective cut-away view of the sheath 4 with thevarious devices (i.e., the two grasping devices 108, the drive cable100, the actuating cable 450, and the endoscope 8) extendingtherethrough. Each of the various devices are further enclosed by one ofa plurality of tubes 510 which allow either a rotational movement (forthe cables 100, 450) or a longitudinal (for the two grasping devices 108and the endoscope 8) movement therein. Similar to the sheath 4, theplurality of tubes extend from a proximal end coupled to the controlhandle 6, to a distal end coupled to the working head assembly 2. Theplurality of tubes 510 provide protection against damage due to, forexample, abrasion, and provide an isolated path through the sheath 4which prevents tangling between the various devices.

FIG. 18 shows a cross-section of the control handle 6 which may be usedin conjunction with a resectioning device of the invention. The controlhandle 6 may preferably be substantially "Y" shaped, with a first branch500 for operating the actuating mechanism 104 and a second branch 502for operating the drive mechanism 102 and a body 520. A receiving hole512 runs longitudinally through the center of the body 520 for receivingthe endoscope 8 therethrough. A first force transferring mechanism 504is coupled to an actuating control knob 508, and extends axially throughthe first branch 500, through the body 520, where it is coupled to theactuating cable 450 which extends through the sheath 4 to connect to theactuating mechanism 104. A second force transferring mechanism 506 iscoupled to a drive control knob 510, and extends axially through thesecond branch 502, through the body 520, where it is coupled to thedrive cable 100 which extends through the sheath 4 to the drivemechanism 102. Those skilled in the art will understand that the controlhandle may be designed in any variety of shapes to accommodate, forexample, different hand sizes, comfort, etc. In addition, differentforce transferring methods may also be used instead of a knob such as,for example, actuating levers, etc.

In operation, the user applies a rotational force to one of the controlknobs 508 and 510, the rotational force is transferred through arespective one of the force transferring mechanisms 504 and 506 whichthen transfers rotational force to a respective one of the drive cable100 and actuating cable 450, thereby operating the actuating mechanism104 or the drive mechanism 102 as described above.

FIG. 11 shows a device according to a second embodiment of the presentinvention in which like reference numerals identify the same elements.

The anvil member 10 of this embodiment preferably has a substantiallycircular or elliptical cross-section and is gradually tapered from theproximal face 14 to its distal end 16, forming a bullet-like structure.This tapered shape allows the device to be more easily inserted into thepatient's body as the distal end 16 has a smaller cross-sectional sizethan in the first embodiment. Those skilled in the art will understandthat the anvil member 10 may have other tapered shapes besides abullet-like structure without departing from the scope of the presentinvention.

Instead of providing the cut-out 13 shown in the first embodiment toreceive the endoscope 8 therein, a substantially cylindrical firstendoscope lumen 13 extends axially through the center of the anvilmember 10. The distal end 16 of the anvil member 10 may preferably havea beveled edge 54 adjoining the first endoscope lumen 13 to allow for anexpanded field of forward vision via the endoscope 8.

The proximal housing 12 may preferably have a cross-sectioncorresponding in size and shape to the cross-section of the proximalface 14 of the anvil member 10 (i.e., substantially circular orelliptical). In this embodiment, the cavity 30 in the first embodimenthas been omitted and a substantially cylindrical second endoscope lumen52 extends axially through the center of the proximal housing 12.

However, as in the previous embodiment, two grasper holes 32, 33 extendaxially through the proximal housing. The two grasper holes 32 and 33may preferably be disposed between the mounting holes 26a and 26b sincethe first endoscope lumen 13 now extends through the axial center of theproximal housing 12. In addition, the grasper holes 32, 33 in thisembodiment may preferably have a substantially circular cross-section.However, those skilled in the art will understand that thecross-sectional shape of the grasper holes 32 and 33 may be selected to,for example, accommodate another type of device.

A receiving sleeve 55 is provided on the proximal end 12b of theproximal housing 12 for receiving the endoscope 8 and for guiding theendoscope 8 into the proximal housing 12. The receiving sleeve 55 maypreferably have a first section 56 and a second section 58. The firstsection 56 and second section 58 may preferably both have an annularcross-section forming a continuous center hole 59 therethrough. Thecenter hole 59 has a diameter which preferably corresponds to thediameter of the receiving hole 52 so that the endoscope 8 may becontinuously received through the center hole 59 into the secondendoscope lumen 52 in the proximal housing 12. The second section 58preferably has a thicker wall than the first section 56, such that anannular ring formed by the cross-section of the second sections 58 has alarger width than an annular ring formed by the cross-section of thefirst section 56.

In contrast to the endoscope lumen 40 disposed along the periphery ofthe sheath 4 as shown in FIG. 1, the endoscope lumen 40 in thisembodiment preferably runs along an axial center of the sheath 4, sothat when the sheath 4 is coupled to the working head assembly 2, asubstantially continuously aligned path is formed through the centerhole 59, through the second endoscope lumen 52, and through the firstendoscope lumen 13. The actuating shafts 400 and 105 and the drivecables 450 and 102 are then located concentric to the endoscope lumen 40in the sheath 4.

FIG. 12 shows a device according to a third embodiment of the presentinvention. The proximal face 14 of the anvil member 10 of thisembodiment has a cross-section similar to the crescent-shapedcross-section of the anvil member 10 of the device of FIG. 1. Thus, theanvil member 10 has two horns 22a and 22b formed on either side of acut-out 13 which extends axially through the anvil member 10 from theproximal face 14 to the distal end 15 to receive the endoscope 8therein. As with the device of FIG. 11, the cross-sectional size of theanvil member 10 diminishes in overall size from a maximum at theproximal face 14 to a minimum size at the distal end 15, and the horns22a and 22b become less pronounced from the proximal face 14 to thedistal end 15. In a side view, the anvil member 10 becomes graduallytapered from the proximal end 14 to the distal end 16.

As in the device of FIG. 11, the tapered shape of the anvil member 10 ofthe device of FIG. 12 allows for easier insertion of the device into thepatient's body.

In contrast to the second embodiment, the cut-out 13 provides a largerfield of vision via the endoscope 8 as the anvil member does not totallyenclose the cut-out 13. And, as in the first embodiment, twosubstantially cylindrical mounting shafts 20a and 20b are coupled to theproximal face 14 of the anvil member 10 on horns 22a and 22b and arereceived within the mounting holes 26a and 26b, respectively.

In contrast to the previous embodiments, the proximal housing 12 in thisembodiment may preferably have a substantially oval cross-sectionalshape. This shape of the proximal housing 12 is formed by extending theproximal housing 12 shown in FIG. 1 around the cutout 29 to create thesubstantially cylindrical second endoscope lumen 52. The oval shapeallows the second endoscope lumen 52 to be offset from the axial centerof the proximal housing 12 and aligned with the first endoscope lumen13. This offset of the second lumen 52 allows the cavity 30 to beprovided adjoining the blade slit 36. In all other material respects,the proximal housing 12 in this embodiment is substantially identical tothe proximal housing 12 illustrated in FIG. 1.

FIG. 13 shows a device according to a fourth embodiment of the presentinvention. This embodiment is substantially similar to the embodimentshown in FIG. 12. However, the proximal face 14 of the anvil member 10in this embodiment has a substantially oval-shaped cross-sectioncorresponding to the proximal housing 12. The anvil member 10 is taperedtowards the distal end 16 to form a substantially bullet-like structurehaving an oval-shaped cross-section. The cut-out 13 shown in FIG. 12 maypreferably be enclosed within the anvil member 10 and thereby forms anextension of the first endoscope lumen 13.

A substantially semicircular shield 31 extends from the proximal face 14of the anvil member 10 and shields a hemispherical portion of the gapformed between the anvil member 10 and the proximal housing 12. Theshield 31 allows a tissue section to be drawn primarily in the gapbetween the staple-forming grooves 19 and the staple slits 34 withminimal spill-over into the rest of the gap.

A recessed groove 35 may preferably be formed around a portion of theproximal housing 12 for slidably receiving the shield 31 therein. Therecessed groove 35 may preferably have a size and shape substantiallycorresponding to the size and shape of the shield 31 so that when theanvil member 10 is in its proximal most position, the shield 31 isreceived within the recessed groove 35 to form a substantiallycompletely continuous outer surface of the proximal housing 12.

In operation, the user may utilize suction through the endoscope 8 todraw a tissue section into the gap between the anvil member 10 and theproximal housing 12. In such a situation, the shield 31 prevents aportion of the tissue section or loose debris from being pulled into thearea around the mounting shafts 20a and 20b which may otherwiseinterfere with the axial movement of the mounting shafts 20a, 20b. Inaddition, the shield 31 also serves to direct the pulling force of thesuction to pull tissue primarily in the gap between the staple-forminggrooves 19 and the staple slits 34.

FIGS. 14a and 14b show a device according to a fifth embodiment of thepresent invention in which the working head assembly 2 is coupled to theendoscope 8 without the sheath 4. As described above, distal ends 500aof control cables 500 (i.e., drive cable 100 and actuating cable 450)may preferably be coupled to the working head assembly 2 while proximalends 500b of the control cables 500 are coupled to the control handle 6as in the previous embodiments. However, instead of using a flexiblesheath 4 to receive the control cables 500 and the endoscope 8, thecontrol cables 500 are inserted into respective tubes 510. Each of thetubes 510 should have a sufficient cross-section to allow the controlcables 500 to rotate within the tubes 510. The tubes 510 are thenfastened at various predetermined points along their lengths to theendoscope 8 by a plurality of fasteners 502. Those skilled in the artwill understand that many different types of fasteners may be usedeither alone or in combination for this purpose so long as the fastenersdo not impede the steering of the endoscope 8 or the rotation of thecables 500. Those skilled in the art will understand that tape (e.g.,surgical, electrical, etc.), electrical cable, rubber bands, otherbelt-style fasteners, etc. may be used as fasteners.

FIGS. 16-18 illustrate alternative configurations of the blade housing74b and it will be understood that similar alternative embodiments maybe implemented for the blade housing 74a.

The blade slit 36 continues through the blade housing 74b into housingporion 84b which extends from a forward end at which the blade slit 36enters the blade housing 74b to a rearward end where the blade slit 36and the housing portion 84b terminate. A shield receiving slit 480extends through the blade housing 74b substantially perpendicular to thehousing portion 84b between the forward and rearward ends thereof.

After an organ section has been stapled between the anvil member 10 andthe proximal housing 12, and the blade 202 is drawn through the stapledtissue, there may be a problem if tissue stretches along with the blade202 into the housing portion 84b without being completely severed.Withdrawal of the resectioned tissue might then lead to tearing of thetissue which is to remain in place.

As seen in FIG. 17, a flexible breakaway shield 482 having a shape andsize substantially corresponding to the shape and size of the shieldreceiving slit 480 is inserted into the shield receiving slit 480. Afterentering the housing portion 84b, the cutting blade 202 contacts theshield 482 and further progress of the blade 202 deforms the shield 482until the shield 482 is cut in half. When the shield 482 is cut in half,each half snaps back pulling the tissue in a direction opposite thedirection of travel of the blade allowing the cutting blade 202 tocompletely sever the tissue.

FIG. 18 shows a second alternative arrangement in which a flexible gate484, having a first gate half 484a and a second gate half 484b, may beremovably or fixedly mounted within the shield receiving slit 480. Eachof the halves 484a and 484b may preferably be mounted within arespective half of the shield receiving slit 480, so that a small gapformed therebetween substantially corresponds in width to the width ofthe cutting blade 202. The wiping action in a direction opposed to thedirection of travel of the blade 202 is substantially the same as thatof the shield 482 without requiring the severing and replacement of theshield 482 after each use.

FIGS. 19a and 19b show a third alternative arrangement in which a pairof tissue blockers 600 and 602 facilitate the cutting of the resectionedtissue. Although, the following discussion will focus on the firsttissue blocker 600, those skilled in the art will understand that asimilar arrangement may be provided on the second tissue blocker 602.

As shown in FIG. 19a, the first tissue blocker 600 is composed of afirst rectangular bar 610 and a second rectangular bar 612 situated at afirst end 21a of the guiding slit 21. The first rectangular bar 610 hasa first base 610a and the second rectangular bar 612 has a second base612a, which are both fixedly coupled to the proximal face 14 of theanvil member 10 and arranged so that the bases 610a, 612b straddle bothsides of the guiding slit 21 with a gap formed therebetweencorresponding to the width of the guiding slit 21.

A first slot 614a is provided in the first base 610a of the firstrectangular bar 610, and a second slot 614b is provided in the secondbase 612a of the second rectangular bar 612 so that when the rectangularbars 610, 612 are coupled to the anvil member 10, the flexible breakawayshield 482 (shown in FIG. 17) may be disposed within the slots 614a,614b. As shown in FIG. 19c, a pair of L-shaped holes 620, 622 areprovided on both ends of the blade slit 30 on the distal end 12a of theproximal housing 12. The L-shaped holes 620, 622 extend longitudinallywithin the proximal housing 12 to receive the rectangular bars 610, 612therein when the anvil member 10 is coupled to the proximal housing 12.

This arrangement operates similarly to the arrangement shown in FIG. 17,so that the wiping action of the shield 482 in a direction opposite to amovement of the blade 202 allows the blade 202 to completely cut throughthe resectioned tissue. Although the shield 482 is initially a singlepiece in a first operation of the device, the shield 482 may be re-usedwithout replacement in further operations with minimal diminishment ofits effectiveness.

FIG. 20 shows a device according to a sixth embodiment of the presentinvention in which like reference numerals identify the same elements.The sheath 4 is substantially more rigid and shorter than in previousembodiments. Although this decreases the effective operative range ofthe device, the rigidity of the sheath 4 increases its overallstructural strength, allowing greater forces to be transferredtherethrough to the working head assembly 2 than in the previousembodiments. The cables 100, 450 driving the various mechanisms 102, 104may then need to be stronger and stiffer in order to accommodate theincreased forces. As a result of these changes, the overall size of theworking head assembly 2 may then be increased to, for example, treatlesions that may be too large for the devices according to the previousembodiments to treat in a single procedure.

FIGS. 21-25 show a device according to a seventh embodiment of thepresent invention in which the working head assembly 2 comprises theanvil member 10, a stapler member 17, and a connecting adapter 25. Asshown in FIG. 21, the anvil member 10 and the stapler member 17preferably have substantially semi-circular shapes complementary to oneanother such that, when they are positioned adjacent to each other, theyform a substantially annular clamp-like device (as shown in FIG. 23).The anvil member 10 and the stapler member 17 are pivotally connectedvia a substantially cylindrical hinge-pin 60 which is provided on adistal end 25a of the connecting adapter 25. A proximal end 25b of theconnecting adapter 25 may preferably be coupled to the sheath 4 in amanner similar to that in which the proximal housing 12 is connected tothe sheath 4 in the previous embodiments. Those skilled in the art willunderstand that the shape of the anvil member 10 and the stapler member17 may be modified to accommodate specific needs or applications withoutdeparting from the scope of the present invention.

As shown in FIG. 22, a plurality of first ring-like extensions 10b areformed on a first end 10a of the anvil member 10. The first extensions10b may preferably be separated a predetermined distance from oneanother to form a plurality of spaces in which a corresponding pluralityof second ring-like extensions 17b formed on a first end 17a of thestapler member 17 are accommodated. The first extensions 10b maysubstantially correspond in shape and size to the second ring-likeextensions 17b so that when the first anvil end la and the first staplerend 17a are engaged, an alternating arrangement of first and secondextensions lob, 17b is formed in which the holes of each of the firstand second extensions 10b, 17b are substantially aligned to form acontinuous hole in which a hinge-pin 60 is received. Thus, the hinge-pin60 and the first and second extensions 10b, 17b form a hinge whichallows the anvil member 10 and the stapler member 17 to pivot about thehinge-pin 60. A locking ring 62 may preferably be attached to a distalend 61 of the hinge-pin 60 to secure the first and second extensions10b, 17b to the hinge-pin 60.

A first anchoring joint 23a is formed on an interior face 10i of theanvil member 10. The first anchoring joint 23a may preferably have asubstantially triangular cross-section viewed along the longitudinalaxis of the working head assembly 2. However, a side of the firstanchoring joint 23a that is attached to the anvil member 10 maypreferably be convex in shape complementary to the concave shape of theinterior face 10i of the anvil member 10. A substantially similar secondanchoring joint 23b is formed on an interior face 17i of the staplermember 17 having a size and shape corresponding to the size and shape ofthe anchoring joint 23a.

As shown in FIG. 23, first and second coupling elements 64a, 64b aredisposed on respective anchoring joints 23a, 23b to couple the anchoringjoints 23a, 23b to two rod links 150a, 150b, respectively. The rod links150a, 150b provide a rigid coupling between the anchoring joints 23a,23b and a distal end 154 of a push rod 152. Thus, a longitudinal forcein a distal or proximal direction applied to the push rod 152 istransferred to the anchoring joints 23a, 23b, and thereby to the anvilmember 10 and the stapler member 17.

In operation, when a distally directed pushing force is applied to thepush rod 152, the force is transferred through the link rods 150a, 150bto the anvil member 10 and the stapler member 17 via the respectiveanchoring joints 23a, 23b, gradually separating an anvil head 10c on theanvil member 10 from a stapler head 17c on the stapler member 17 untilthey reach a tissue receiving position. Similarly, when a proximallydirected pulling force is applied to the push rod 152, the anvil head10c and the stapler head 17c are drawn toward one another until theyreach a stapling position, in which the anvil head 10c and the staplerhead 17c are adjacent to one another separated by a narrow gap. As theanvil head 10c and the staple head 17c are drawn together by the pushrod 152, a stabilizer tongue 308 extending from the stapler head 17c ofthe stapler member 17 is gradually received within a stabilizing groove304 on the anvil head 10c. This tongue/groove arrangement provides aguide and a securing/stabilization mechanism for the anvil member 10 andthe stapling member 17.

The anvil head 10c is disposed on a second end 10e of the anvil member10 that is opposite to the first end 10a thereof. The anvil head 10c maypreferably have a substantially rectangular cross-section larger than across-sectional size of the rest of the anvil member 10.

The anvil head 10c has an anvil face 10d on which a plurality ofstaple-forming grooves 19 may preferably be arranged in two offset,substantially straight lines. In addition, a substantially straightguiding slit 21 may preferably extend substantially along the center ofthe anvil face ld, substantially parallel to the lines of staple-forminggrooves 19, while the stabilizing groove 304 is preferably formed alonga distal side of the anvil face 10d for receiving the stabilizer tongue308. The stabilizing groove 304 may preferably have a shape and sizesubstantially corresponding to the stabilizing tongue 308 so that thestabilizing tongue 308 is snugly received within the stabilizing groove304 when the anvil member 10 and the stapler member 17 are in thestapling position.

As shown in FIG. 23a, the stapler head 17c is formed on a second end 17eof the stapler member 17 opposite to the first end 17a thereof, andpreferably has a cross-section corresponding, at least in the areaadjacent to a stapler face 17d, to the size and shape of the anvil head10c. A plurality of staple slits 34 are arranged on the stapler face 17din positions corresponding to the position of the staple-forming grooves19 on the anvil head 10c so that when the stapler face 17d and anvilface 10d are positioned adjacent to each other, each of the plurality ofstaple slits 34 is substantially aligned with a corresponding one of theplurality of staple-forming groove 19. Additionally, a substantiallystraight blade slit 36 extends across the stapler face 17d correspondingto the guiding slit 21 on the anvil head 10c so that when the staplerhead 17c and the anvil head 10c are positioned adjacent to one another,the blade slit 36 is substantially aligned with the guiding slit 21.

As shown in FIG. 23, the distal end 25a of the connecting adapter 25preferably has a cross-section corresponding to the shape and size ofthe peripheral surface of the annular clamp-like shape formed by theanvil member 10 and the stapler member 17 so that a substantiallysmooth, continuous outer surface is formed by the anvil member 10, thestapler member 17, and the connecting adapter 25 when the anvil member10 and the stapler member 17 are in the stapling position. Theconnecting adapter 25 is preferably gradually tapered from the distalend 25a to the proximal end 25b thereof, and the proximal end 25b maythen be coupled to the sheath 4 as shown in FIG. 24. As further shown inFIG. 24, a substantially cylindrical endoscope lumen 52 preferablyextends axially through the center of the connecting adapter 25 forreceiving a conventional endoscope 8 therethrough. The connectingadapter 25 may also have a substantially cylindrical rod hole 322extending axially along the periphery of the connecting adapter 25extending through an area adjacent to the hinge-pin 60, for receivingthe push rod 152 therein.

As shown in the cut-away view of FIG. 25, a track 350 is provided withinthe stapler head 17c extending within the stapler head 17c from an areaadjacent to a distal end 352 of the stapler head 17c to an area adjacentto a proximal end 354 thereof. FIG. 26 shows a cutaway view of thestapler head 17c showing the track 350 having a substantially L-shapedcross-section. The track 350 may preferably be situated so that a firstleg 350a of the track 350 extends substantially beneath the plurality ofstaple slits 34 on the staple face 17d, and a second leg 350b of thetrack 350 extends substantially beneath the blade slit 21 on the stapleface 17d.

In a first configuration shown in FIG. 25, a wedge-sled 402 is provided(instead of the wedge 402 described in the previous embodiments) on adistal end 350a of the track 350. The wedge-sled 402 has a cut-out in acorner forming a cam surface 412 thereon and a blade handle 408. Thisprovides the wedge-sled 402 with a substantially L-shaped cross-sectionsubstantially corresponding to the cross-sectional shape of the track350. The wedge-sled 402 is arranged in the track 350 so that the camsurface 412 is substantially disposed in the first leg 350a of the trackfacing toward the plurality of staple slits 34. Furthermore, thewedge-sled 402 is arranged in the track 350 so that the blade handle 408is subsantially disposed in the second leg 350b beneath the blade slit21. Thus, when the cutting blade 202 is coupled to the blade handle 408,the cutting blade 202 extends out of the blade slit 21 as in theprevious embodiments. As shown in FIG. 26, the stabilizing tongue 308has a receiving slit 309 for receiving the cutting blade 202 thereinwhen the wedge-sled 402 is positioned at the distal end 350a of thetrack 350. This prevents unintentional cutting of tissue as the deviceis inserted and guided within the organ.

As shown in FIG. 25, an actuating cable 450 for operating the staplerhead 17c is coupled to the leading edge 402d of the wedge-sled 402 andextends through the track 350, through a tube 332 (which is coupled tothe proximal end 354 of the stapler head 17c and extends through thesheath 4 to the control handle) of the plurality of tubes 510 (shown inFIG. 9d), and is then coupled to the control handle 6 (not shown).

In operation, the wedge-sled 402 is initially positioned at the distalend 350a of the track 350 with the blade 202 received within thereceiving slit 309 of the stabilizing tongue 308 as the operatormaneuvers the device to a desired location within the body. While thedevice is being maneuvered to the desired location, the anvil member 10and the stapler member 17 are located adjacent to each other in thestapling position. When the desired position is reached, the operatorpushes the push rod 152 distally to separate the anvil member 10 and thestapler member 17 into the tissue receiving position. Then the operatordraws the portion of tissue to be resectioned into the gap between thestapler member 17 and the anvil member 10 and draws the push rod 152proximally to return the anvil member 10 and the stapler member 17 tothe stapling position, gripping the tissue to be resected within thegap. The operator then pulls actuating cable 450 proximally, drawing thewedge-sled 402 towards the proximal end 350b of the track 350. As thecam surface 412 on the wedge sled passes beneath each one of theplurality of staple slits 34, the cam surface 412 drives each one of aplurality of staple drivers 472 (each being disposed within acorresponding one of the staple slits 34) sequentially driving aplurality of staples out of the staple slits 34 to staple the tissuegripped between the anvil head 10c and the stapler head 17c. Inaddition, the cutting blade 202 coupled to the blade handle 408 of thewedge-sled 402 is pulled through the blade slit 21 to resection thetissue which has now been stapled off from the organ.

When the tissue has been resectioned, the operator pushes the operatingcable 450 distally to return the cutting blade 202 to the receiving slit309 of the stabilizing wedge 308. The device may then be withdrawn fromthe body.

As shown in FIGS. 23 and 25, the anvil member 10 and the stapler member17 have a tissue receiving position shown in FIG. 25, and a staplingposition shown in FIG. 23. Therefore, it is necessary to allow theactuating cable 450 disposed within the tube 332 and received within thestapler head 17c to correspondingly move with the stapler member 17.Accordingly, a channel 330 is provided in the connecting adapter 25 toreceive the tube 332 therein. The channel 330 may preferably be formedwithin the connecting adapter 25 to substantially correspond to the arcpath along which the tube 332 is pulled by the stapler member 17, as thestapler member 17 moves between the tissue receiving and the staplingpositions. Thus, the channel minimizes bending and crimping of the tube332.

Those skilled in the art will understand that although the proximalhousing 12 in any of the embodiments may preferably be composed of ametallic-type material, the proximal housing 12 may also be composed ofa clear plastic-type material which would allow the user to operate theworking head assembly 2 under visual observation by partiallywithdrawing the endoscope 8 into the second endoscope lumen 52 in theproximal housing 12.

The user could then look through the walls of the endoscope lumen 52into the proximal housing 12 to, for example, observe whether each ofthe plurality of staple drivers 472 have been actuated. In addition, theuser may also observe whether the wedge 402 shown in FIGS. 10a and 10bis locked into the blade portion 420 as described above. Alternatively,selected portions of the proximal housing 12 may be composed of theclear plastic-type material providing a "window" to view through theproximal housing 12.

Those skilled in the art will also understand that although theabove-described embodiments show mechanical force transmission betweenthe control handle and the working head assembly, this device couldalternatively include an electronic control for receiving input from anoperator coupled to a series of motors in the working head assembly.Those skilled in the art will further understand that the relativepositioning of the stapling mechanisms and the position adjustingmechanisms to each other may be reversed, placing the staplingmechanisms in a distal-most position in relation to the positionadjusting mechanism. The above described embodiments are for purposes ofillustration only and the various modifications of these embodimentswhich will be apparent are considered to be within the scope of theteachings of this invention which is to be limited only by the claimsappended hereto.

What is claimed is:
 1. A full-thickness resection system for removing afull-thickness portion of a body organ using a flexible endoscope, thesystem comprising:a stapling mechanism which, in an operative positionis located within a body of a patient, wherein the endoscope is slidablyreceived through at least a portion of the stapling mechanism, thestapling mechanism comprising: an anvil; a stapling head rotatablycoupled to the anvil so that the anvil and the stapling head may rotatewith respect to one another between a tissue receiving position and astapling position, wherein a gap formed between the stapling head andthe anvil is larger in the tissue receiving position than it is in thestapling position; a position adjusting mechanism for rotating at leastone of the anvil and the stapling head relative to the other of theanvil and the stapling head between the tissue receiving and staplingpositions; a staple firing mechanism for sequentially firing, when thestapling head and the anvil are in the stapling position, staplesreceived in the stapling head from the stapling head across the gapagainst the anvil and through any tissue received in the gap, and aknife for cutting a portion of tissue received within the gap; a bladeshield attached to said anvil or said stapling head and adapted todefine a blade gap through which said blade travels, said blade gaphaving a width corresponding to a width of said knife, said blade shielddisposed to resist movement of a portion of the tissue encountered bysaid knife, and a control unit which, when the stapling head is in theoperative position, remains outside the body, the control unit beingcoupled to the stapling mechanism for controlling operation of theposition adjusting mechanism and the staple firing mechanism.
 2. Thefull-thickness resectioning system according to claim 1, wherein thecontrol unit includes a rotatable control member coupled to the staplingmechanism by at least one longitudinally flexible drive shaft.
 3. Thefull-thickness resectioning system according to claim 2, wherein, in afirst cutting configuration, the knife is coupled to the drive shaft sothat rotation of the drive shaft moves the knife from an initialposition to a final position severing the portion of tissue receivedwithin the gap and wherein in a second non-cutting configuration, theknife is decoupled from the drive shaft so that rotation of the driveshaft does not move the knife between the initial and final positions.4. The full-thickness resectioning system according to claim 1, whereinthe staple firing mechanism includes a plurality of staple firingmembers, each staple firing member being slidably received in arespective one of a plurality of staple slits.
 5. The full-thicknessresectioning system according to claim 1, wherein the stapling mechanismincludes at least one lumen therethrough for receiving a grasper device.6. The full-thickness resectioning system according to claim 1, whereinsaid blade shield is flexible.
 7. The full-thickness resectioning systemaccording to claim 1, wherein, when moved from a initial position to afinal position, the knife severs the blade shield.
 8. The full-thicknessresectioning system according to claim 1, wherein the blade shieldincludes a first portion and a second portion, and wherein the knifepasses between the first portion and the second portion.
 9. Thefull-thickness resection system according to claim 1, wherein saidplurality of staple slits is formed in at least two parallel rows,wherein the anvil includes a plurality of staple-forming groovespositioned so that, when the anvil and the stapling head are in thestapling position, each of the staple slits is substantially alignedwith a respective one of the staple-forming grooves.
 10. Thefull-thickness resection system according to claim 9, wherein thecontrol unit further includes a rotatable control member coupled to aproximal end of the drive shaft.
 11. The full-thickness resection systemaccording to claim 10, wherein the knife is selectively coupleable tothe drive shaft so that, in a first mode of operation, operation of theknife is independent of the firing of the staples.
 12. Thefull-thickness resection system according to claim 1, wherein thestapling head includes a blade slit extending therethrough and whereinthe blade slit and the staple slits extend substantially parallel to thelongitudinal axis of the endoscope.
 13. The full-thickness resectionsystem according to claim 1, wherein the anvil is coupled to thestapling head via a hinge-pin, and wherein the anvil and the staplinghead are moved between the tissue receiving position and the staplingposition by rotating about the hinge-pin.
 14. A method of performing afull-thickness resection of tissue within a substantially tubular bodyorgan comprising the steps of:inserting a stapling mechanism slidablycoupled to an endoscope into a tubular body organ via a body orifice,wherein the stapling mechanism includes a stapling head and an anvilrotatably coupled to one another for rotation between a staplingposition and a tissue receiving position, wherein a gap formed betweenthe stapling head and the anvil is smaller in the stapling position thanin the tissue receiving position; rotating the stapling mechanism intothe tissue receiving position, drawing a section of wall tissue of thebody organ to be resectioned into the gap; rotating the staplingmechanism into the stapling position; firing a plurality of staplesthrough the tissue received in the gap; after the staples have beenfired cutting away from the wall of the body organ a portion of thesection of wall tissue to be resectioned; and resisting movement of allwall tissue extending inwardly from said plurality of staples duringsaid cutting step, whereby said portion of said wall tissue iscompletely severed.
 15. The method according to claim 14, wherein thestapling mechanism is coupled to a controller by at least onetorsionally rigid, longitudinally flexible drive shaft, wherein thecontroller remains outside the body.
 16. The method according to claim15, wherein a longitudinally flexible sheath surrounds the endoscope andthe drive shaft.
 17. The method according to claim 14, wherein theentire resectioning procedure is performed endoluminally.
 18. The methodaccording to claim 17, wherein the stapling mechanism is maneuvered intoa desired position adjacent to the tissue to be resectioned by steeringthe flexible endoscope through the body organ to locate the tissue to beresectioned visually and then sliding the stapling mechanism along theendoscope to the desired position.